Study of the Elevate Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
Trial ID or NCT#
The aim of this study is to further evaluate the safety and efficacy of the Elevate® Anterior and Apical Prolapse Repair System for repair of anterior/apical pelvic organ prolapse in a controlled, post-market cohort study.
A Prospective, Safety and Efficacy Cohort Study of Elevate® Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair
- Subject is female Subject is at least 18 years of age Subject must have documented diagnosis of anterior or anterior and apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥ 0; or Ba ≥ 0 and C ≥ -1/2 TVL (for a multi-compartment anterior prolapse that includes the apical compartment) Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit") Subject or subject's legally authorized representative is willing to provide written informed consent Subject is willing and able to comply with the follow-up regimen
- Subject is pregnant or intends to become pregnant during the study Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical) Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical) Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months) Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica) Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis Subject has uncontrolled diabetes mellitus (DM) Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit) Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis) Subject is not able to conform to the modified dorsal lithotomy position Subject is currently participating in or plans to participate in another device or drug study during this study Subject has a known sensitivity to polypropylene Subject has had previous prolapse repair with mesh in the target compartment Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment